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Hi everyone. We made up a batch of hand sanitizer from GNS because Bloomington is completely sold out. 

I wrote up our recipe here, and would love you're input on this:
https://www.cardinalspirits.com/thedrop/hand-sanitizer-recipes

We’ve seen other distilleries talking about using heads for making sanitizer. While this is probably a fine idea for sanitizing non-porous non-coated surfaces, it’s not smart to use on human skin. Methanol is bad for us, which is why we remove it in the first place, right?

Anyhow, here are our recipe ideas…

Hand sanitizer is simply alcohol + emollient (skin softener).

First, here’s a good explanation of how alcohol mixes with oils.

And here is what we’ve done:

10 Liters of GNS at 95% ABV
2 Liters of mineral oil
1.5 liters of RO water (any water would work)

You need to shake this up pretty good for it to dissolve. And unfortunately, it does come out of solution. We recommend you tell your guests to shake it up before using to redistribute the oil.

The basic recipe is 10L of GNS with 3.5L of some kind of emollient. This nets 14.5L of hand sanitizer at 70% ABV.

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People need to start critically thinking about what is going on. This is the largest attempted Psy Op in very very long time and its got people running round like pawns on the chess board.....

Wow. That was unexpected. Especially in an industry built around Pasteur's work.

The guidance in the document is precisely worded.  The excerpt you quote has three separate sentences, each describing a different set of circumstances.  The three sentences are clear, but you have to

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You can of course use spirits you make if higher enough proof or just use cheap Isopropyl Alcohol you can pickup at the grocery store or drug store (if you don't have it already).

2/3 90% alcohol and 1/3 aloe gel does the trick and ends up at 60% or so which is where you want to be.

There are a bunch of good recipes online including this easy one that anyone can do:

https://www.wired.com/story/how-to-make-hand-sanitizer/

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21 minutes ago, Sudzie said:

Why not use aloe? 2/3 -1/3 ratio. Make sure the final product is above 60%. 

Aloe is pretty expensive, and was currently unavailable in Bloomington. The general point of the post is that you can use any emollient, just make use of what is available to you. And while 60% is a good target, better to err on the side of more ABV and target 70% in case of measurement errors.

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Edit on 23March2020. The information below is out dated due to new guidance and guidelines that have recently changed. I am leaving this post up as current regulation loosening may be temporary. Best to check with the proper authorities for anyone reading this after the covid-19 outbreak passes.

Went over this already.


Hand sanitizer is regulated by the FDA as a OTC drug.  Unless you are licensed as a drug manufacturer and reseller you are treading in dangerous territory. 
https://www.fda.gov/drugs/information-drug-class/topical-antiseptic-products-hand-sanitizers-and-antibacterial-soaps

 

A few have said "we won't call it hand sanitizer."  Well, you can call it whatever you want, but if the feds and/or state say it looks like a duck and quacks like a duck, they are the ones who determine (not you) if it's a duck.

If anyone knows for sure otherwise, please let me know.

FYI one of our suppliers for beverage alcohol is focusing their entire operation towards fulfilling orders for hand sanitizer manufacturers and all beverage alcohol is delayed 2 weeks.  There's the very real chance you could lose your business and 1 day later every Home Depot has 20 pallets of the stuff. 

You probably spent years and your entire life's savings opening a business in a highly regulated industry, don't risk it by treading into another highly regulated industry that you aren't licensed in.

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https://www.fda.gov/media/136118/download

Because of the public health emergency posed by COVID-19, FDA does not intend to take action against compounders that prepare alcohol-based hand sanitizers for consumer use for the duration of the public health emergency declared by the Secretary of HHS on January 31, 2020, provided the following circumstances are present:

It's only 9 pages that are easy to read.

 

I didn't even give thought to selling this when reading the thread and just thought it was for own personal/family use. :)

Interesting they give a recipe using 80% alcohol plus Glycerol (1.45% v/v),  Hydrogen peroxide (0.125% v/v), Sterile distilled water or boiled cold water.

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On 3/14/2020 at 5:36 PM, DrDistillation said:

https://www.fda.gov/media/136118/download

Because of the public health emergency posed by COVID-19, FDA does not intend to take action against compounders that prepare alcohol-based hand sanitizers for consumer use for the duration of the public health emergency declared by the Secretary of HHS on January 31, 2020, provided the following circumstances are present:

It's only 9 pages that are easy to read.

 

I didn't even give thought to selling this when reading the thread and just thought it was for own personal/family use. :)

Interesting they give a recipe using 80% alcohol plus Glycerol (1.45% v/v),  Hydrogen peroxide (0.125% v/v), Sterile distilled water or boiled cold water.

Edit on 23March2020. The information below is out dated due to new guidance and guidelines that have recently changed. I am leaving this post up as current regulation loosening may be temporary. Best to check with the proper authorities for anyone reading this after the covid-19 outbreak passes.

Unless i'm reading this wrong, it does not say distillers can make hand sanitizer

Quote

Specifically, FDA does not intend to take action against pharmacists in State-licensed pharmacies or Federal facilities, for the duration of the public health emergency declared by the Secretary of HHS on January 31, 2020, for violations of sections 501(a)(2)(B), 502(f)(1), and 505 of the FD&C Act (21 U.S.C. 351(a)(2)(B), 352(f)(1), and 355), or against outsourcing facilities for violations of sections 502(f)(1), 505, or 582 of the FD&C Act (21 U.S.C. 352(f)(1), 355, and 360eee-1).

Disclaimer: I have not finished reading it yet.

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Further reading:

Quote

The hand sanitizer is compounded using only the following United States Pharmacopoeia (USP) grade ingredients in the preparation of the product (percentage in final product formulation) consistent with World Health Organization (WHO) recommendations:5

a.Alcohol (ethanol) (80%, volume/volume (v/v)) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20; or Isopropyl Alcohol (75%, v/v) in an aqueous solution.6

b.Glycerol (1.45% v/v).7

c.Hydrogen peroxide (0.125% v/v). d.Sterile distilled water or boiled cold water.The compounder does not add other active or inactive ingredients. Different or additional ingredients may reduce the safety and effectiveness of the product.

2.The compounder pays particular attention to ensure the ethanol or isopropyl alcohol active ingredient is correct and the correct amount of the active ingredient is used.

3.The hand sanitizer is prepared under conditions routinely used by your facility to compound similar nonsterile drugs.8

4.The hand sanitizer is labeled consistent with the attached labeling in Appendix A (Labeling for Ethyl Alcohol Formulation) or Appendix B (Labeling for Isopropyl Alcohol Formulation).

Edit on 23March2020. The information below is out dated due to new guidance and guidelines that have recently changed. I am leaving this post up as current regulation loosening may be temporary. Best to check with the proper authorities for anyone reading this after the covid-19 outbreak passes.

I am not entirely familiar with USP certification or grade. Is what we make USP grade? I'm guessing not.

Ethanol, 80% vv denatured according to TTB.  If you do not have the checkbox for denaturing operations, you can not legally do this.

Mind "The compounder does not add other active or inactive ingredients", so a compounder (pharmacist) may not veer from the above recipe. Also keep in mind that only ethanol can be used which rules out using heads for this purpose.

 

I'm not trying to be a downer. I fully support this and will dedicate all available resources towards this if and only if we can legally do it.

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I had a client inquire about this and I'll make this short and sweet.  You can check references.  To deal, as a distiller,  in industrial alcohol, you must have a permit issued under part 19. This is in addition to the FAA Act basic permit that you hold.  If all you are qualified to do is produce beverage alcohol, and that is probably at least 95% of you, then you also must amend your registrations to include industrial alcohol and must obtain a bond or post a cash bond - minimum $15 operatons and $1K withdrawals..  All of that is easily accomplished, but it takes time.  By the time you do that the shortage will have long ago passed. 

If you qualify to produce industrial alcohol, you are liable for the tax on the head faction.   They haveethyl alcohol in them too. You can destroy the heads and be rid of the tax.  You must keep records of the destruction, prior to the production gauge, as I am sure you all do.

If, prior to the production gauge, you remove the ethyl alcohol so that it is less than 10% of the the product, you might be able to remove the remaining heads from the production account as a chemical byproduct on which you could place a Mr. Yuk sticker.  Read what that requires and decide if you think you have a market.

But undenatured alcohol removed from the DSP for industrial use is subject to tax.  No matter how nasty your heads are, they are not denatured alcohol.  You may also only ship to the authorized industrial user.

You make denatured alcohol according to a formula found in part 21 of the regulations.  You can denature alcohol in your processing account, but you must do that with alcohol you have counted as produced an transferred to the processing account.  The alchol you use to make SDA must be not less than 185 proof, unless otherwise specifically stated in the formula or unless otherwise authorized by the appropriate TTB officer.  You are relived of the tax when you denature the product according to an approved formula.  You may then use certain SDA products to make a sanitizer, which TTB calls an artical, which you may ship from your DSP.  

Okay, it ain't short, but its a lot shorter than it is when I justify what I say by references.  Try §19.307,  §19.308 and §19.381 and following,, along with the links stated therein, as a starter.  Then delve into parts 20 and 21.  And it isn't sweet.  

If you are not keeping track of your heads and recording their destruction, and TTB audits, and the auditor checks, and the auditor cares, then they could cite a violation and enter an assessment.  That is "could."  If you are shipping the stuff out the door as a commercial product, I think an assessment of tax would be likely - I've no experience with this because no one I know of has done it - unless you have used 185 plus to make a denatured product which you then used to make a sanatizer under whatever rules the FDA might apply to such products.

If anyone finds I am wrong, let me know.

 

 

 

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dhdunbar, I think you got it pretty well covered

The document is pretty self explanatory as to what the FDA would allow right now for C-19 and by who and you explained the bond (at a high level) and recording properly as far as I can tell.

Most here probably wouldn't even be able to partner with a local pharmacist due to not having the right type of bond on file to sell them the alcohol assuming it was denatured properly.

Now on a personal/family note, I've been making my own for a while (don't care if it's denatured) but I use aloe and it has worked well.  After reading that doc I'm going to add in a splash of hydrogen peroxide and maybe try Glycerol instead of the aloe as it's a lot cheaper on my next batch.  I also add some food coloring I had in the pantry to tint it as well (purple) so it couldn't be confused for anything else in my household.

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Sorry if this had been covered - the search function may not have been working when I tried looking through older forum posts on my phone before posting.

To reiterate what some other have said, and add my own thoughts:

  1. Don't try to sell this stuff. We're using it in our tasting room because our county is sold out.
  2. Pay taxes on everything, always.
  3. Never use heads in anything that will touch a human. Methanol and humans are chemically incompatible in every possible way.

I did speak with the manager of a high-volume corporate pharmacy today about sanitizer. He has received no word from supply chain that more is on its way, and asked me personally to deliver a few gallons so that he and his staff could refill the pump dispensers at their POS stations.

It seems clear that hand sanitizer should be a last resort after washing with soap and water, and just avoiding contact in the first place. But if we're going to sustain some level of normality, it seems sanitizer can function as a security blanket if nothing else.

Thanks,

AQ

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For home brew type sanitizer I'd have zero issue using "heads" (I do) from any of the mashes/washes I make.  Just not enough methanol to worry about IMHO.  I'm not drinking it and it's just skin content which I'll wash off anyway.

What I do after being in public is use my alcohol based sanitizer THEN rinse with at least water.  My sanitizer is strong (70%+) of alcohol (from heads runs) so it kills germs but I don't want it lingering on my skin so I at least rinse with water to rinse off any residual alcohol.  Wouldn't want to light a cig or cigar or work around the stove without a quick rinse first to dilute any residual alcohol on the skin even though most would just evaporate and probably never be an issue.

From my own personal/family standpoint I look at it from killing germs, bacteria, virus first then neutralizing alcohol then softening skin with anything of your choosing including aloe if you have it.

We (people here on this forum) understand alcohol and instinctively know to do quick rinse with water after killing germs to not become a fire hazard.  That is part of FDA responsibility to make sure people are safe with products high in alcohol.  Some dumb smuck who doesn't know better could rinse with a high alcohol sanitizer, lean over his kerosene heater in the family room and poof... We on the other hand can can bacteria, virus, etc with alcohol, then rinse with water and then soften skin as 3 separate steps.

Teach your family/friends(if you share) how to use alcohol to kill germs and rinse with water to be safe  and then use something to keep skin soft and not dried out from the alcohol evaporating from skin.

Does that make sense or no?

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People need to start critically thinking about what is going on.

This is the largest attempted Psy Op in very very long time and its got people running round like pawns on the chess board.....

Germ theory has never been proven. The allopaths in the " know " are aware of this fact and also that Pasteur and others of this ilk were mostly  frauds. If you " believe " anything you are in serious trouble. No virus has ever been proven to cause sickness in the human kingdom. Also no vaccine has ever been proven to be effective. Its all very clever mind control from the get go.

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11 hours ago, starcat said:

People need to start critically thinking about what is going on.

This is the largest attempted Psy Op in very very long time and its got people running round like pawns on the chess board.....

Germ theory has never been proven. The allopaths in the " know " are aware of this fact and also that Pasteur and others of this ilk were mostly  frauds. If you " believe " anything you are in serious trouble. No virus has ever been proven to cause sickness in the human kingdom. Also no vaccine has ever been proven to be effective. Its all very clever mind control from the get go.

4 MORE YEARS!!1!

a perfect troll or an incredible dufus

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Thank you so much Starcat for the much needed belly laugh. I had no idea Russian trolls had infiltrated the ADI Forums, but here we are!

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Read the DISCUS attachments before jumping in.  Then wait until TTB puts out the rules. TTB needs  to waive some things and I'm not sure that they can do it, since they can't grant any waivers that would be contrary to law.  §19.29 gives them broad authority, "Whenever TTB finds it is necessary to meet the requirements of national defense or necessary or desirable by reason of disaster, TTB may temporarily exempt the proprietor from any provisions of the internal revenue laws and the provisions of this part relating to distilled spirits, except those requiring the payment of tax."  The phrase "those relating to the payment of tax" might be read broadly, but TTB's rules, when issued, will give you a safe haven. 

In the meantime, use soap.  From what I read, it works a lot better.  

And, from  someone who knows, by either one or two degrees of separation, over 20 people who have tested positive for covid-19, I've got to add "Stay safe."  Only one of them has died - age 43 by the way - but a few more have felt like they were going to and all were at a minimum inconvenienced by being isolated in their own home.  One, who did not know she had it, met with eight others.  Five of them tested negative; three positive.  That's a damned high transmission rate, but its anecdotal.  

 

 

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Good news. So it sounds like there’s still approval required from the FDA and then individual states, right?

 

not trying to be a Debbie downer. Just want to ensure I am staying in full compliance.

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FYI:  For every 55g drum of GNS you can make ~400 16oz(~.5l) bottles My math could be wrong so if someone could check it please do. I should be close though. 

55g GNS : (How to submit a TIB through PONL" http://adiforums.com/topic/11486-ponl-how-to-submit-a-tib/) - My approval was one day. 

5g Glycerin: https://www.chemworld.com/Four-Gallons-ChemWorld-Glycerin-USP-p/cw-glycerinusp-4.htm

1g of 32% H202 (hydrogen peroxide):  https://www.chemworld.com/Hydrogen-Peroxide-p/cw-54-5.htm (this is to be watered down to 3%)

You now have everything you need to know and sources. You just need to hit up a bottle supplier. I called around and most are very picked over or have holds for medical/government. You can get them but it might be ugly. 

 

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On 3/14/2020 at 5:36 PM, DrDistillation said:

https://www.fda.gov/media/136118/download

Because of the public health emergency posed by COVID-19, FDA does not intend to take action against compounders that prepare alcohol-based hand sanitizers for consumer use for the duration of the public health emergency declared by the Secretary of HHS on January 31, 2020, provided the following circumstances are present:

It's only 9 pages that are easy to read.

 

I didn't even give thought to selling this when reading the thread and just thought it was for own personal/family use. :)

Interesting they give a recipe using 80% alcohol plus Glycerol (1.45% v/v),  Hydrogen peroxide (0.125% v/v), Sterile distilled water or boiled cold water.

That is the WHO formula. That is what the TTB will now allow...

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